Clarence Thomas

Summary

Clarence Thomas Wyeth v. Levine, 555 U.S. 555… (2009 | noyear)

III The origins of this Court's "purposes and objectives" pre-emption jurisprudence in Hines, and its broad application in cases like Geier, illustrate that this brand of the Court's pre-emption jurisprudence facilitates freewheeling, extra textual, and broad evaluations of the "purposes and objectives" embodied within federal law. This, in turn, leads to decisions giving improperly broad pre-emptive effect to judicially manufactured policies, rather than to the statutory text enacted by Congress pursuant to the Constitution and the agency actions authorized thereby.
Source: Wikisource

Clarence Thomas Wyeth v. Levine, 555 U.S. 555… (2009 | noyear)

In addition, the text of the statutory provisions governing FDA drug labeling, and the regulations promulgated there under, do not give drug manufacturers an unconditional right to market their federally approved drug at all times with the precise label initially approved by the FDA. Thus, there is no "direct conflict" between the federal labeling law and the state-court judgment. The statute prohibits the interstate marketing of any drug, except for those that are federally approved.
Source: Wikisource

Clarence Thomas Wyeth v. Levine, 555 U.S. 555… (2009 | noyear)

See 21 U.S.C. § 355 (a) ("No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) of this section is effective with respect to such drug" (emphasis added) ) . To say, as the statute does, that Wyeth may not market a drug without federal approval (i.e., without an FDA-approved label) is not to say that federal approval gives Wyeth the unfettered right, for all time, to market its drug with the specific label that was federally approved.
Source: Wikisource

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